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Vertex Pharmaceuticals’ Orkambi has been approved as the first drug intended to treat cystic fibrosis in patients who have two copies of a specific mutation, the FDA announced Friday. Read More
The FDA Thursday told stakeholders at a public hearing that manufacturers of naloxone may switch their products from prescription-only to over-the-counter as long as they can show that it can be used effectively by consumers guided by product labeling alone. Read More
The FDA is investigating the potential risks of medicines containing codeine to treat coughs and colds in children 18 and younger because of the potential for serious side effects, according to a safety announcement released Wednesday. Read More
Gilead Sciences has submitted an NDA for a once-daily single tablet regimen to treat HIV-1 infection in adult and pediatric patients 12 years and older, using a priority review voucher that it acquired from Knight Pharmaceuticals for $125 million in November 2014. Read More
Galderma has received FDA approval for its injectable gel Restylane Lyft with lidocaine to correct age-related volume loss in the cheek area for people over 21, offering a nonsurgical option to help restore cheek fullness. Read More
A federal judge in New Jersey ordered a Hamilton, N.J., company charged with marketing unapproved and misbranded suppositories to destroy its stock and discontinue manufacturing the products. Read More
The full House of Representatives could vote on the 21st Century Cures Act as early as Thursday after the House Rules Committee meets to consider possible amendments to the bill. Read More